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Exercise program aims to boost health in severe mental illness

NCT ID NCT05834309

Disease control Sponsor: Universidad Pública de Navarra Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a 6-week exercise program, done twice a week, can improve physical and mental health in 100 adults with severe mental illness. Participants are randomly assigned to either usual care or usual care plus the exercise program. The goal is to see if exercise reduces metabolic syndrome risk and improves quality of life, fitness, and mood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * resident in Navarra * diagnosis of severe mental disorder (DSM 5: Schizophrenia 295.90, Tr. Schizoaffective Disorder 295.70, Schizotypal Personality Disorder 301.22, Schizoid Personality Disorder 301.20, Schizophreniform Personality Disorder 295.40, Psychotic Disorder with Delusional Ideas 295.40, Psychotic Disorder with Delusional Ideas 295.40. Schizophreniform 295.40, Psychotic disorder with delusions 293.81, Psychotic disorder with hallucinations 293.82, Major depressive disorder 296.33, Bipolar disorder type I 296.44, Bipolar disorder type II 296.89, Obsessive Compulsive Disorder 300. * primary nursing diagnosis NANDA and Virginia Henderson NOC 0099 Ineffective Health Maintenance * at least one of the secondary nursing diagnoses 001 Nutritional Imbalance due to Excess, 003 Risk of Nutritional Imbalance due to Excess, 00096 Sleep Deprivation, 00146 Anxiety or 00168 Sedentary * willing to voluntarily participate in the randomly assigned intervention, after signing the informed consent form. Exclusion Criteria: * acute illness that does not allow physical exercise sessions or assessments during the study * medical contraindication that prevents physical exercise * treatment with Interleukin-6 receptor antagonists (tocilizumab) during the last month due to drug interference with adaptations to cardiopulmonary exercise * refusal to sign the informed consent form by the study subject * impossibility of follow-up.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Cognitive Dysfunction Health Behavior mental disorder metabolic syndrome X Motor Activity psychiatric disorder Sedentary Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Exercise Health-related behavior Mental deterioration Mental disorders, severe Metabolic syndrome Physical disability Physical inactivity Severe mental disorder

Contacts and locations

Locations

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Fundacion Miguel Servet

    Pamplona, Navarre, 31008, Spain

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